‘Right to Try Act’ Would Make Access to Investigational Drugs Easier

Monica Luhar for KCET, Published May 27, 2015

http://www.kcet.org/news/agenda/laws/the-right-to-try-act-would-make-it-easier-for-terminally-ill-patients-to-access-investigational-drug.html

A California bill allowing patients with life-threatening illnesses the chance to try to save their life through the use of unapproved drugs or medical devices has moved forward with bipartisan support on the Assembly floor.

The Right to Try Act, authored by assemblymember Ian Calderon, would permit a manufacturer of an investigational drug to make the option immediately accessible to eligible patients. “The bill removes barriers to accessing potentially life-saving drugs for terminally ill patients and doctors who believe an investigational drug or device could be their last hope for survival,” Calderon told KCET via email.

Investigational drugs have not yet been approved by the FDA.
AB 159 would also authorize — but not require — a health benefit plan to provide coverage for any investigational drug, biological product, or device for terminally ill patients, according to Calderon.

Under AB 159, eligibility would be dependent on written and informed consent by patients. The administering of the drug would also depend on whether a patient has a terminal illness that will likely result in death in the near future, has been unable to participate in clinical trials, and has considered other treatment options.

The bill comes in the midst of parallel discussions circling around aid in dying in California, SB 128, or the End of Life Option Act. If signed into law, SB 128 would provide mentally competent, terminally ill Californians the chance to utilize lethal prescriptions to terminate their life and alleviate discomfort and pain during their final days.

Most recently, the California Medical Association was lauded for dropping its opposition to medical aid-in-dying and becoming neutral on the controversial bill. Additionally, a lawsuit was filed May 15 on behalf of three Californians with terminal illnesses, on the grounds that the California constitution and existing law allow aid-in-dying.

AB 159 — the Right to Try Act — is similar to SB 128 in one aspect: providing end of life options for terminally ill patients.

While the FDA has implemented a program that makes investigational drugs and devices available to patients with life-threatening disease, the process can take several months for approval, Calderon said.

“The FDA announced a streamlined application process in February but the process is not yet approved and is in the public comment period,” he said. “Terminally ill patients who have exhausted all other options are unable to wait months to gain access to potentially life-saving investigational drugs and devices.”

Under the Right to Try Act, patients would have improved access to investigational treatments.

“The lengthiness of the FDA approval process delays potentially life-saving drugs from reaching the market in a timely manner,” said Calderon.

Right to Try legislation has been introduced in 22 states so far. Similar measures have passed in other states with bipartisan support.

“The terminally ill do not have the luxury of waiting — not when they have weeks or months left to live.”

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